COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04494646

Sripal Bangalore, MD, MHA

Sripal.Bangalore@nyulangone.org

2020-07-31

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: laboratory-confirmed covid-19 infection as determined by polymerase chain reaction (pcr) hospitalized patients that meets one of the following conditions: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.); or at rest, blood oxygen saturation ≤ 94%; or require supplemental oxygen; or requiring non-invasive ventilation; or requiring invasive mechanical ventilation for up to 2 days. age ≥ 18 years. enrollment of patients ≥70 years of age may be limited (e.g., comprise no more than 10% of all randomized patients), pending safety review by the dsmb and executive committee participant or legally authorized representative is willing to give informed consent

intubated and on invasive mechanical ventilation for three or more days at the time of randomization known left ventricular ejection fraction (lvef) <40% or prior hospitalization for heart failure cardiac arrest shock known uncontrolled bacterial, fungal, or non-covid viral infection egfr <30 ml/min/1.73 m² or requiring dialysis alt or ast > 5x uln history of cirrhosis, chronic active hepatitis or severe hepatic disease pregnant or lactating women enrolled in other trial of unapproved therapies, unless approved by trial principal investigator. in general, co-enrollment will be permitted unless there are safety concerns, mechanistic incompatibility or inability to adjudicate serious adverse events and will be decided on a case by case basis. if in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments

2

NYU Langone Health

18

100

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

40

Number of Serious Adverse Events

None

Phase 2

[{"arm_notes": "", "treatment_id": 180, "treatment_name": "Bardoxolone methyl", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]